Evidence map›Paper›PMID 24347462›Full record

Trial reportPediatric blood & cancer2014

Time to disease progression in children with relapsed or refractory neuroblastoma treated with ABT-751: a report from the Children's Oncology Group (ANBL0621).

Elizabeth Fox, Yael P Mosse', Holly M Meany, James G Gurney, Geetika Khanna, Hollie A Jackson, Gary Gordon, Suzanne Shusterman, Julie R Park, Susan L Cohn and 4 more

Registry-linked trialOpen access · greenAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Pediatric blood & cancer, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00436852 (A Phase II Study of ABT-751, an Orally Bioavailable Tubulin Binding Agent, in Children With Relapsed or Refractory Neuroblastoma), which is not on this map. Cited by 7 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 1 pooled it
2.0field-weighted citation impact, top 14% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00436852 phase2completednot on this map

A Phase II Study of ABT-751, an Orally Bioavailable Tubulin Binding Agent, in Children With Relapsed or Refractory Neuroblastoma

TypeinterventionalSponsorChildren's Oncology GroupRan2007 to 2015Enrolled92ConditionsDisseminated Neuroblastoma, Recurrent NeuroblastomaArmsABT-751, quality-of-life assessment
3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 1 synthesis or guideline pooled it, 18 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Article
  4. Article
  5. Article
  6. Article
  7. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors at 9 institutions in 1 country.

Elizabeth FoxThe Children's Hospital of Philadelphia, Philadelphia, Pennsylvania.
Yael P Mosse'
Holly M Meany
James G Gurney
Geetika Khanna
Hollie A Jackson
Gary Gordon
Suzanne Shusterman
Julie R Park
Susan L Cohn
Peter C Adamson
Wendy B London
John M Maris
Frank M Balis
Children's Hospital of Philadelphia · USBoston Children's Hospital · USAbbott Fund · USChildren's Hospital of Los Angeles · USChildren's National · USSeattle Children's Hospital · USSt. Jude Children's Research Hospital · USUniversity of Chicago · USWashington University in St. Louis · US

Funding

NCTN BIQSFP ANBL1531 (NRT)U10CA180886 · NCI · PUBLIC HEALTH INSTITUTE · PI Douglas S. Hawkins · 2014 to 2026
$390.6M
COG FOREIGN ACCRUALU10CA098543 · NCI · NATIONAL CHILDHOOD CANCER FOUNDATION · PI ADAMSON, PETER C. · 2003 to 2013
$335.5M
COG SDMC - Statistics CoreU10CA180899 · NCI · UNIVERSITY OF SOUTHERN CALIFORNIA · PI TODD A ALONZO · 2014 to 2026
$132.8M
Children's Oncology Group Statistics &Data Center GrantU10CA098413 · NCI · UNIVERSITY OF NEBRASKA MEDICAL CENTER · PI ANDERSON, JAMES R · 2003 to 2013
$67.5M
Pediatric Pilot/Phase I Consortium - Foreign AccrualU01CA097452 · NCI · NATIONAL CHILDHOOD CANCER FOUNDATION · PI BLANEY, SUSAN M. · 2002 to 2011
$28.2M
NCI NIH HHS U01 CA097452NCI NIH HHS U10 CA098413NCI NIH HHS U10 CA 098453NCI NIH HHS U10 CA098543NCI NIH HHS U10 CA180886NCI NIH HHS U10 CA180899NCI NIH HHS U10 CA98413
6 · The paper itself

Abstract

backgroundABT-751, an orally bioavailable sulfonamide binds the colchicine site of beta-tubulin and inhibits microtubule polymerization. Prior phase I studies established the recommended dose in children with solid tumors as 200 mg/m(2) PO daily × 7 days every 21 days and subjects with neuroblastoma experienced prolonged stable disease. We conducted a phase 2 study (NCT00436852) in children and adolescents with progressive neuroblastoma to determine if ABT-751 prolonged the time to progression (TTP) compared to a hypothesized standard based on a historical control population. PROCEDURE: Children and adolescents (n = 91) with a median (range) age 7.7 (2.3-21.5) years and progressive neuroblastoma were enrolled and stratified by disease status into disease measureable by CT/MRI (n = 47) or disease assessable by (123) I-metaiodobenzylguanine scintigraphy (MIBG, n = 44). Response was evaluated using RECIST for measureable disease and the Curie score for MIBG-avid disease.

resultsABT-751 was well tolerated. The objective response rate was 7%. The median TTP was 42 days (95% CI: 36, 56) in the measureable disease stratum and 45 days (95% CI: 42, 85) in the MIBG-avid disease stratum. TTP was similar to the historical control group (n = 136, median TTP 42 days). For the combined strata (n = 91), 1-year progression free survival (PFS) was 13 ± 4% and overall survival (OS) was 48 ± 5%.

conclusionsThe low objective response rate and failure to prolong TTP indicate that ABT-751 is not sufficiently active to warrant further development for neuroblastoma. However, this trial demonstrates the utility of TTP as the primary endpoint in phase 2 trials in children and adolescents with neuroblastoma.

Indexed as

Salvage TherapyAdolescentAntineoplastic AgentsBiomarkersCapsulesChildChild, PreschoolCombined Modality TherapyDisease-Free SurvivalDisease ProgressionFemaleGastrointestinal DiseasesHematologic DiseasesHumansMaleNervous System DiseasesABT751Antineoplastic AgentsBiomarkersCapsulesSulfonamidesSuspensionsTubulin Modulatorschildhood cancerclinical trialmicrotubule inhibitorneuroblastomatime to progression

Identifiers

PMID24347462
PMCPMC5127168
OpenAlexW1939383910

What OpenQuestion holds

Textmetadata
LicenceTDM
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.